efficacy and safety of recombinant human fgf21-fc fusion protein for injection (tqa2225/ap025) in adult subjects with non-alcoholic steatohepatitis (nash)

Conditions: Non-alcoholic Steatohepatitis

Summary: a randomized, double-blind, placebo-controlled phase ii study，to evaluate the efficacy and safety of tqa2225/ap025 in patients with non-alcoholic steatohepatitis (nash)


Eligibility criteria:
inclusion criteria: * must be willing to participate in the study and provide written informed consent. * male or female aged 18 ≤ age \< 75 at the time of signing the informed consent. * must have had prior liver biopsy within 180 days of randomization with fibrosis stage 1 to 3 and a nas of ≥4 with at least a score of 1 in each of the lobular inflammation and ballooning degeneration. * confirmation of ≥10% liver fat content on magnetic resonance imaging-derived proton density fat fraction (mri-pdff). * weight changes≤5% in the 6 weeks prior to randomization. * no qualitative change in dose for the drugs listed below: 1. antidiabetic treatment if glucagon-like peptide-1 receptor agonists (glp1 receptor agonists) or sodium-glucose co-transporter-2 inhibitors (sglt2 inhibitors): for at least 3 months 2. vitamin e (if at a dose ≥400 iu/day): for at least 6 months 3. statins: for at least 3 months * females of childbearing potential must practice a consistent and proper use of highly effective method of contraception throughout the study and for 6 month after treatment discontinuation. exclusion criteria: * documented causes of chronic liver disease other than nash * type 1 diabetes or uncontrolled type 2 diabetes defined as:hemoglobin a1c ≥9% at screening，fasting blood glucose≥13.9mmol/l * uncontrolled hypertension at screening (values ≥160/100 mm hg) * history or presence of cirrhosis * subjects with any type of active malignancy or a history of malignancy (except cervical cancer or non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma and papillary thyroid carcinoma) that has been cured for more than 5 years prior to the screening period; * unable or unwilling to undergo liver biopsy according to research requirements. * history of weight loss surgery within 5 years (inclusive) prior to screening * a major surgery was performed 3 months prior to signing the informed consent form (icf), or planned during the study period. * have experienced any bone trauma, fracture, or bone surgery within ≤ 2 months prior to screening. * when screening, according to the results of dual energy x-ray absorptiometry (dxa) examination, it meets the criteria for osteoporosis: t≤ -2.5 * recent history of drug abuse (defined as ≤ 2 years). * patient participating in other clinical trials of drugs or medical devices within 3 months prior to screening. * abnormal laboratory test values：alt or ast \>5 × uln；serum alp≥2× uln；egfr\ 1.3× uln；platelets \< lln. * pregnant or breastfeeding women. * liver transplantation history or planned liver transplantation * contraindications for mri examination * any other condition which, in the opinion of the investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes.